The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

No text entered.

Reporting Groups

Description

Cervarix Group

Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.

Havrix Group

Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

The Total Vaccinated cohort included all vaccinated subjects with at least 1 vaccine administration documented.

Reporting Groups

Description

Cervarix Group

Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.

Havrix Group

Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.

Measured Values

Cervarix Group

Havrix Group

Participants Analyzed [Units: Participants]

3730

3740

Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms. [Units: Subjects]

Any fatigue

512

502

Grade 3 fatigue

6

5

Any myalgia

257

232

Grade 3 myalgia

0

1

Any arthralgia

58

64

Grade 3 arthralgia

0

1

Any gastrointestinal

191

171

Grade 3 gastrointestinal

0

0

Any headache

714

718

Grade 3 headache

2

0

Any rash

15

17

Grade 3 rash

0

0

Any urticaria

19

21

Grade 3 urticaria

0

0

Fever (oral) >= 37.5°C

472

477

Fever (oral) > 39.0°C

0

0

No statistical analysis provided for Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms.

11. Secondary:

Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms on a 10% Random Subset of Participants. [ Time Frame: From Day 3 to Day 6 after vaccination ]

Limitations of the study, such as early termination leading to small numbers of participants
analyzed and technical problems with measurement leading to unreliable or uninterpretable data

The following analysis "occurence of histopathologically confirmed CIN2+ cases associated with HPV16 or HPV18 infection was not performed, in accordance with the Statistical Analysis Plan submitted to the FDA.